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Regulatory Affairs Analyst

Company Name: McGuff Pharmaceuticals, Inc.
Location: Santa Ana, CA
Job Type: Full Time
Contact Name: Austin McGuff
Phone:
Fax:
Email: This email address is being protected from spambots. You need JavaScript enabled to view it.
Salary: DOE

Job Description

McGuff Pharmaceuticals, Inc. (a subsidiary of McGuff Company, Inc.) is an FDA registered and ISO 9001 certified company with a reputation for outstanding commitment to quality and customer satisfaction. 

McGuff Pharmaceuticals, Inc. currently has an opening for a Regulatory Affairs Analyst within our Manufacturing Division located in Santa Ana, CA.  This position reports to the Senior Regulatory Affairs Specialist. 

Duties include:
Responsible for coordinating and implementing activities related to future and ongoing Regulatory Affairs support of the product development process, submissions and regulatory compliance including:

  • Act as a core member on manufacturing and development teams, providing Regulatory Affairs feedback and guidance throughout the product development cycle.
  • Assist in the preparation and submission of regulatory applications, as well as internal regulatory file documentation.
  • Review product labeling and advertising materials for compliance with global submissions and applicable regulations
  • Help develop and implement regulatory strategies for new and current pharmaceutical products.
  • Act as a company representative, developing and maintaining positive relationships with outside consultants and regulators through oral and written communications.
  • Maintain site registrations and licenses.
  • Develop/revise/implement departmental policies and procedure affecting regulatory affairs.



Job Requirements

Qualifications include:

  • Education: Bachelor of Science/Arts degree, preferably in a scientific or technical discipline, or comparable additional experience.
  • Minimum of 1-5 years relevant industry experience in Regulatory Affairs. Additional QA/QC experience in pharmaceutical manufacturing desirable.
  • Understanding of FDA and international regulations. RAPS Certification desirable.
  • Preferred candidate will have direct experience with successful filing of domestic (e.g. NDA/ANDA) and international marketing applications for injectable pharmaceuticals.
  • Knowledge of domestic and international product compliance requirements.
  • Computer literate and familiar with computerized documentation. Ability to create and manage eCTD.
  • Knowledge of FDA cGMP requirements.
  • Ability to manage multiple projects.
  • Effective research and analytical skills.
  • Excellent written and oral communication, technical writing and editing skills. 

Expectations:

  • Appropriate professional demeanor.
  • Ability to maintain strict confidence and discretion.
  • Acquire knowledge of and assure compliance to corporate policies and procedures.
  • Work with all McGuff employees to foster and promote quality.
  • High regard for Trust, Integrity, Honesty, Ethics, Innovations and Safety in self and others.
  • High sense of Responsibility, Ownership, Accountability.
  • Capable of Flexibility in work requirements/conditions and willingness to embrace change
  • Results driven and a hands on approach to completion of assigned tasks